Phase
Condition
Cervical Cancer
Uterine Disorders
Treatment
Cadonilimab combined with cisplatin
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Histologically confirmed cervical carcinoma, FIGO stage IB3, IIA2, IIB, IIIC1, and assessed as resectable by the researcher。
Inclusion Criteria:
Female, age ≥18 years;
Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, andassessed by the researcher as resectable;
No previous systemic treatment for the current disease, including surgicaltreatment, antitumor chemoradiotherapy/immunotherapy, etc.;
Patients who agree to undergo radical surgical treatment and are judged by thesurgeon to have no surgical contraindications;
ECOG score of 0-1;
Expected survival time >6 months;
Sufficient organ function, the subject must meet the following laboratoryindicators:
Neutrophil absolute count (ANC) ≥1.5x10^9/L ; Platelets ≥100x10^9/L ;Hemoglobin >9g/dL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range
Exclusion
Exclusion Criteria:
Diagnosis of other malignancies within 5 years prior to the first dose (excludingadequately treated basal cell carcinoma of the skin, squamous cell carcinoma of theskin, and/or carcinoma in situ that has undergone radical resection).
Current participation in an interventional clinical study or receipt of otherinvestigational drugs or devices within 4 weeks prior to the first dose.
Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targetingother stimulatory or co-inhibitory T-cell receptors .
Systemic treatment with Chinese herbal medicines with antitumor indications orimmunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding localuse for pleural effusion control) within 2 weeks prior to the first dose.
Active autoimmune disease requiring systemic treatment (e.g., disease-modifyingagents, glucocorticoids, or immunosuppressants) within 2 years prior to the firstdose. Replacement therapies (e.g., thyroxine, insulin, or physiologicglucocorticoids for adrenal/pituitary insufficiency) are not considered systemictreatment.
Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other localroutes) or any immunosuppressive therapy within 7 days prior to the first dose.
History of allogeneic organ transplantation (excluding corneal transplants) orallogeneic hematopoietic stem cell transplantation.
Known hypersensitivity to any study drug.
Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).
Inadequate recovery from prior intervention-related toxicity or complications (i.e., >Grade 1 or not returned to baseline, excluding fatigue or alopecia).
Known history of Human Immunodeficiency Virus( HIV) infection .
Untreated active hepatitis B (HBV)(defined as HBsAg-positive with HBV-DNA exceedingthe upper limit of normal at the study site).
Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above thelower detection limit).
Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
Pregnant or lactating women.
Severe or uncontrolled systemic diseases, including:Symptomatic restingElectrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade IIheart block, ventricular arrhythmia, atrial fibrillation).Unstable angina,congestive heart failure, or chronic heart failure ≥NYHA class II.Arterialthromboembolism, ischemia, myocardial infarction, unstable angina, stroke, ortransient ischemic attack within 6 months prior to enrollment.Poorly controlledhypertension (systolic >140 mmHg, diastolic >90 mmHg).History of non-infectiouspneumonitis requiring glucocorticoids within 1 year or current active interstitiallung disease.
Active tuberculosis.
Active or uncontrolled infection requiring systemic therapy.
Clinically active diverticulitis, abdominal abscess, or gastrointestinalobstruction.
Liver diseases (e.g., cirrhosis, decompensated liver disease, acute/chronic activehepatitis).
Poorly controlled diabetes (fasting blood glucose >10 mmol/L).
Urine protein ≥++ on urinalysis with 24-hour urine protein >1.0 g.
Psychiatric disorders impairing compliance.
Any condition (e.g., medical history, abnormal lab/test results, concurrenttreatments) that may interfere with study outcomes, participation, or pose risks, asjudged by the investigator.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaActive - Recruiting

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